pembrolizumab alone (n=296) vs. paclitaxel (n=296)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously every 3 weeks
paclitaxel
paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of 4week cycles
Patients in the paclitaxel group were not permitted to cross over to receive pembrolizumab.
mGC or mGEJC - L2 - all population
open label
148 medical centres in 30 countries
P3/ one sided and one interim analysis. Repartition OS/PFS and hierachy PDL1 et pop tot
Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher.
KEYNOTE-061 (PDL1 CPS>1), 2018 NCT02370498
pembrolizumab alone (n=196) vs. paclitaxel (n=199)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously every 3 weeks
paclitaxel
paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of 4week cycles
Patients in the paclitaxel group were not permitted to cross over to receive pembrolizumab.
mGC or mGEJC - L2 - PDL1 positive
open label
148 medical centres in 30 countries
P3/ one sided and one interim analysis. Repartition OS/PFS and hierachy PDL1 and pop tot
Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher.